DeRoyal PROSPERA FLEX User Manual
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DeRoyal PROSPERA FLEX User Manual

Negative pressure wound therapy 7 day single-use system
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CLINICIAN AND PATIENT USER MANUAL
Negative Pressure Wound Therapy
7 Day Single-Use System

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  • Page 1 CLINICIAN AND PATIENT USER MANUAL Negative Pressure Wound Therapy 7 Day Single-Use System...

  • Page 2: Organization Of The Manual

    ORGANIZATION OF THE MANUAL The Prospera Flex™ Single-Use Negative Pressure Wound Therapy System is a prescription medical device for use under the instruction of a licensed and trained clinician. THIS USER MANUAL CONTAINS Intended use, contraindications, and warnings Listing of all symbols and icons with definitions...

  • Page 4: Table Of Contents

    WOUND SUITABILITY FOR PROSPERA FLEX THERAPY . . . . . . . . . . . . . . . . .
  • Page 5 TABLE OF CONTENTS, CONT. BATTERY STATUS AND REPLACEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 BEFORE SHOWERING .

  • Page 6: Important Safety Information

    Read and understand all safety instructions to ensure proper use and to minimize risk of injury. о This User Manual is a component of the Prospera Flex System. о Keep this User Manual in an accessible location. о Include this User Manual when transferring the device to third parties.
  • Page 7 For additional copies of any Prospera Flex literature, please contact DeRoyal Customer Service. US: 1.800.251.9864 Prospera Flex literature may be downloaded from the DeRoyal website at deroyal.com...

  • Page 8: Introduction

    INTRODUCTION The Prospera Flex™ NPWT Single-Use System subsequently named “Prospera Flex”, disposable Single-Use system for patients who have hard-to-heal wounds. Therapy is accomplished by the electronically controlled pump unit delivering a continuous negative pressure at -80 mmHg to the wound...
  • Page 9 PROSPERA FLEX™ SINGLE-USE NPWT SYSTEM INCLUDES PROSPERA FLEX™ CARRYING BAG NPWT SINGLE-USE SYSTEM 45CC CANISTER PROSPERA PROPEL™ WITH TUBING FX DOME TWO (2) AA LITHIUM QUICK REFERENCE GUIDE BATTERIES...

  • Page 10: Symbols

    Type BF Applied Part 1 re-use Manufacturer Keep Dry Temperature Limitation for Date of Operation, Transport and Manufacture Storage Sterilized by Part Number STERILE EO Ethylene Oxide Lot Number MR Unsafe Serial Number deroyal.com/symbols For a list of symbols used in this manual, visit...

  • Page 11: Indications For Use

    The therapy is to be used 24 hours a day, or as directed by a clinician. INTENDED PATIENT POPULATION The Prospera Flex system is intended to be used on adult patients exhibiting conditions as described in the Indications for Use. The...

  • Page 12: Contraindications

    If unsure, refer to the prescribing physician before using the device. WOUND SUITABILITY FOR PROSPERA FLEX THERAPY The Prospera Flex system should be used on wounds with low to medium exudate flow rates that: Are difficult to heal.

  • Page 13: Warnings And Cautions

    о Before use, thoroughly inspect device, including its accessories and tubing, for breaks, cracks, damage, or defects. о The Prospera Flex™ device must be connected only to a Prospera Flex disposable exudate canister and suitable negative pressure wound dressing to enable its continuous and safe operation.
  • Page 14 In the event that defibrillation is required disconnect the pump from the canister before the patient is defibrillated. MR Unsafe. The Prospera Flex pump is not MRI compatible. Do not take the Prospera Flex pump into the MRI suite or near MRI equipment.
  • Page 15 Patient size and weight should be considered when prescribing therapy. Weight Range for therapy is 30-150kg (70-330lbs). The Prospera Flex system is unsuitable for use in areas where there is a danger of explosion (e.g. hyperbaric oxygen or nitrous oxide) or in the presence of a flammable anesthetic mixture or with oxygen or nitrous oxide.
  • Page 16 The pump should be carried in a manner that provides a patient or clinician access to regularly check the status of the pump. When the Prospera Flex system is used on patients with fragile skin, a skin protectant should be used.
  • Page 17 The use of negative pressure presents a risk of tissue ingrowth into foam when foam is used as a wound filler. When using foam as a filler with the Prospera Flex™ system, tissue ingrowth may be reduced by using a wound contact layer, wrapping the foam in gauze, or increasing the frequency of dressing changes.

  • Page 18: Adverse Reactions

    CAUTIONS The Prospera Flex™ device must be connected only to a Prospera Flex disposable exudate canister and suitable negative pressure wound dressing to enable its continuous and safe operation. Read and understand all safety instructions and directions for use included with all NPWT wound dressing kits, canisters and accessories.

  • Page 20: Licensed And Trained Clinician Tasks

    LICENSED AND TRAINED CLINICIAN TASKS INITIAL VISIT: SET-UP THE DEVICE CHECK SYSTEM COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 SELECT THE WOUND DRESSING .
  • Page 21 LICENSED AND TRAINED CLINICIAN TASKS CHANGE THE CANISTER TURN PUMP OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 DISCONNECT CANISTER AT BOTH ENDS .

  • Page 22: Patient And Caregiver Tasks

    PATIENT AND CAREGIVER TASKS ROUTINE MONITORING MONITOR THE SYSTEM OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 CHECK THE BATTERY STATUS .
  • Page 23 PATIENT AND CAREGIVER TASKS CLEANING CLEAN UNIT AND CANISTER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 CHANGE THE CANISTER TURN PUMP OFF .
  • Page 24 THE PROSPERA FLEX™ SYSTEM COMPONENTS The Prospera Flex™ NPWT System is comprised of a Prospera Flex unit, batteries, dome, canister, and component accessories provided by DeRoyal. The following figures have been provided as graphical representation of the entirety of the Prospera Flex system and component accessories.

  • Page 25: Device Controls And Status Indicators

    DEVICE CONTROLS AND STATUS INDICATORS Pump ON/OFF Button Leak Status Pump Status Battery Life Status...

  • Page 26: Selecting The Wound Dressing

    SELECT THE WOUND DRESSING The Prospera Flex™ device is designed to operate safely and effectively using CAUTION a suitable negative pressure wound Do not use any dressing or therapy dressing as determined by a wound filler components licensed and trained clinician.

  • Page 27: Activate The Device

    ACTIVATE THE DEVICE о The therapy clock starts running as soon as the batteries are activated and lasts for 7 days, after which the pump must be replaced by a new one. о The pump is delivered preset at 80mmHg and cannot be modified. о...

  • Page 28: Preparing The Device

    USING THE DEVICE PREPARING THE DEVICE Before starting therapy, follow these important steps: Confirm pump is connected to canister. To connect the pump to the canister, open the back of the pump and insert canister face- down. See Changing the Canister on pg 32.
  • Page 29 PREPARING THE DEVICE, CONT. Confirm wound dressing is applied properly and is securely connected to the canister and the Prospera Flex™ device. Confirm all tubing, and tubing connections are open and free from kinks or other blockages. о Ensure patient is not lying on tubing.
  • Page 30 USING THE DEVICE TURNING THE PUMP ON All lights flash Followed by: and buzzer BEEPS Press the ON/OFF Green light flashes indicating Therapy button firmly for indicating normal Day. See Therapy approximately 2 operational state. Day Indicator table seconds. on Page 43. TURNING THE PUMP OFF All lights go The Therapy Day will...

  • Page 31: Monitoring The Device

    MONITORING THE SYSTEM OPERATION Check the pump regularly. The pump is running when the green OK light is flashing. See Notifications and Troubleshooting on page 44 for other pump alerts. Check the dressing regularly. о When the system is running normally, look for a compressed appearance at the dressing surface.

  • Page 32: Changing The Canister

    3 days, as the wound may have a higher-than-expected exudate flow rate. CHANGING THE CANISTER The Prospera Flex™ device can be connected only to canisters provided by DeRoyal and used only with suitable negative pressure wound dressings to enable continuous and safe operation.
  • Page 33 CHANGING THE CANISTER, CONT. Check the canister fill status. EMPTY о The canister is full when there is loose fluid seen within the canister that is not being absorbed. PARTIALLY о The canister can be changed FULL without disturbing the wound dressing.
  • Page 34 CHANGING THE CANISTER Appropriately dispose of canister, including black clip and tubing. See Removal and Disposal on page 49 . Replace the canister by inserting the bottom tab and rocking the clip of the new canister into the housing until it clicks. Close canister door.
  • Page 35 CHANGING THE CANISTER, CONT. Check the pump. о The pump is running normally when the OK light is flashing. о See Notifications and Troubleshooting on page 44 for other pump alerts. Check the dressing. о When the system is running normally, look for a compressed appearance at dressing surface.

  • Page 36: Setting Up The Carrying Bag

    SETTING UP THE CARRYING BAG Place device inside case by sliding in top-first with device facing out to allow access to power button and alarm indicators. Secure over case with tubing protected wrap any excess tubing in elastic holder. Close case by lowering flap and securing velcro.
  • Page 37 BATTERY STATUS Description and Battery Status Display Status Troubleshooting Green OK light and yellow LOW BATTERY light flashes. Low Battery Therapy still working. Replace with lithium batteries as soon as possible. All lights OFF. Pump does not work when ON/OFF button pressed. Dead Battery Therapy not working.
  • Page 38 BATTERY REPLACEMENT Replace with 2 x AA/L91 lithium batteries (Energizer Ultimate Lithium are recommended.) о Other types of AA batteries such as alkaline batteries can be used in an emergency but will have a shorter life and may run out unexpectedly.

  • Page 39: Before Showering

    BEFORE SHOWERING DO NOT use the device while showering or bathing. Patients and caregivers should consult your licensed and trained clinician for detailed instructions on proper personal care while receiving therapy. Turn the pump OFF. Disconnect the canister from the dome.
  • Page 40 BEFORE SHOWERING Protect the wound from direct spray from the shower and do not submerge in water. AFTER SHOWERING Put on the carrying bag holding the canister and pump. Reconnect the canister to the dome. Push and twist the connector clockwise. Route and fasten the tubing and straps to ensure they do not become kinked or entangled.

  • Page 41: After Showering

    A compressed appearance means the transparent wound dressing is properly adhered to skin, the Prospera Flex™ dressing dome is properly adhered to the transparent wound dressing, and negative pressure is active. If the exudate tube is blocked the dressing may appear loose on the wound.

  • Page 42: Daily Activities

    DAILY ACTIVITIES The unit may be worn while performing daily activities, like sitting, walking, driving, WARNING and sleeping. Patients and caregivers If therapy is discontinued should consult your licensed and trained or disrupted for more than clinicians for detailed instructions on 2 hours, seek emergency appropriate personal activities while medical attention.

  • Page 43: Therapy Day Indicator

    THERAPY DAY INDICATOR Check the current Therapy Day at any time by turning the pump OFF and then ON again. The Therapy Day is shown before normal operation starts. For Therapy Day 1, all the lights flash and the buzzer BEEPS once. For Therapy Day 7, all the lights flash and the buzzer BEEPS 7 times.

  • Page 44: Notifications And Troubleshooting

    NOTIFICATIONS AND TROUBLESHOOTING If machine will not operate, ensure batteries are inserted correctly. Contact WARNING your clinician if a problem cannot be If therapy is discontinued resolved. or disrupted for more than 2 hours, seek emergency medical attention. Light/Audible Possible Display Status Troubleshooting Status...
  • Page 45 NOTIFICATIONS AND TROUBLESHOOTING, CONT. Light/Audible Possible Display Status Troubleshooting Status Causes Yellow LEAK light Leak and low Replace with and yellow LOW battery. new batteries BATTERY light as soon as flashes. Air leak possible. detected Buzzer BEEPS. possibly due Check to a creased connections Pump running.
  • Page 46 NOTIFICATIONS AND TROUBLESHOOTING Light/Audible Possible Display Status Troubleshooting Status Causes All lights ON, and Therapy Time Contact a buzzer sounds Complete. licensed and continuously for trained clinician 10 seconds. to assess the wound Followed by: and replace All lights OFF, the system if Therapy buzzer OFF, and...
  • Page 47 NOTIFICATIONS AND TROUBLESHOOTING, CONT. Light/ Possible Display Status Audible Troubleshooting Causes Status Yellow LEAK Turn pump OFF. Vacuum level light ON is greater Check clamps, all continuously, than normal tubing, and tubing buzzer ON therapy connections for continuously. range. blocks or kinks. Possible Disconnect the closed/...

  • Page 48: Cleaning

    MAINTENANCE The Prospera Flex unit is maintenance free and will not require service. The batteries may be replaced if required. See Battery Status and Replacement on page 30. If the pump fails due to a manufacturing...

  • Page 49: Removal And Disposal

    At the end of therapy or when replacing batteries, remove and dispose of the batteries in accordance with local regulations. Local protocols for disposal of the Prospera Flex™ pump should be based on the applicable federal, state and/or local government environment regulations for recycling electronic devices.

  • Page 50: Warranty

    This warranty does not cover accessories, spare parts, and consumables (including batteries). To the extent allowed by law DeRoyal’s written warranties are given in lieu of any implied warranties, including warranties of merchantability or fitness for a particular purpose.

  • Page 51: Specifications

    SPECIFICATIONS Item Specifications Pump NP-8007D Canister NP-8045C Item Number Dome NP-190F Carrying Bag NP-8007B Electrical Type BF Classification The dressing component and Dome are considered Applied Parts applied parts under IEC 60601-1. Mode of Operation Continuous, Internally powered, portable. Operating Time 7 Days Battery Type Lithium AA Primary (L91)

  • Page 52: Safety And Emc

    The Prospera Flex unit should not be used near high frequency (HF) surgical equipment of near MRI equipment or rooms. The “Essential Performance” of the Prospera Flex unit is that it should not deliver a Negative Pressure to the wound exceeding -225mmHg.
  • Page 54 Fax | 800.543.2182 Website | deroyal.com/npwt Part #: 0-1962 REV: 10/2023 © 2023 DeRoyal Industries, Inc. All rights reserved. DeRoyal, the DeRoyal logo, Prospera, the Prospera Flex logo, Prospera Propel and Prospera Flex are trademarks or registered trademarks of DeRoyal Industries, Inc.

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